Loss and bereavement in late life (60+): Study protocol for a randomized controlled trial regarding an internet-based self-help intervention

BACKGROUND: The death of a close person is a highly stressful, yet common life event in later life. While most individuals seem to cope well with bereavement, a substantial proportion of older individuals suffer from prolonged grief symptoms. E-mental health interventions have been shown to be efficient for a variety of psychological illnesses. Yet, there is a large research gap of studies with a special focus on older adults. This study protocol describes a randomized controlled trial for an internet-based self-help intervention addressing bereavement and loss in adults aged 60 years and over. The self-management intervention is based on techniques of cognitive behavioral therapy and consists of 8 modules. The objective of the AgE-health study is to evaluate the effectiveness and acceptability of this intervention in comparison to a bibliotherapy control group. METHODS: The AgE-health study aims at implementing a randomized controlled trial. Eligible participants aged 60+ years will be randomly allocated to an intervention group (access to the intervention) or to an active control group (access to bibliotherapy). Primary outcome is the reduction in grief symptoms (13-item Prolonged Grief Inventory); secondary outcomes are depression, social activity and network, quality of life, self-efficacy, satisfaction with the intervention/bibliotherapy, loneliness, acceptability, up-take and adherence. Assessments will take place before the intervention (baseline) as well as 4 months (follow-up 1) after the intervention. DISCUSSION: This study addresses an under-recognized and understudied mental health burden in later life and may add valuable insight into our knowledge about the effectiveness of eHealth interventions for loss and bereavement in late life. To our knowledge, the AgE-health study will be the first randomized controlled trial to evaluate the effectiveness of an internet-based intervention targeting prolonged grief in adults aged 60 years and over. TRIAL REGISTRATION: The study has been registered at the German Clinical Trials Register (Identifier: DRKS00020595, Registered 30th July 2020, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00020595).